Site Quality Specialist I - Temp/Contract at NeoGenomics Laboratories in Durham, North Carolina

Job Description:

Are you motivated to participate in a dynamic, multi-tasking environment? Do you want to join a company that invests in its employees? Are you seeking a position where you can use your skills while continuing to be challenged and learn? Then we encourage you to dive deeper into this opportunity.

NeoGenomics is looking for a Site Quality Specialist to support operations at our lab in Durham (RTP), NC who wants to continue to learn in order to allow our company to grow.

This is a full-time, hybrid, temporary/contract position that covers a work schedule of Monday-Friday, 8:30am-5:00pm.

Now that you know what we're looking for in talent, let us tell you why you'd want to work at NeoGenomics:

As an employer, we promise to provide you with a purpose driven mission in which you have the opportunity to save lives by improving patient care through the exceptional work you perform. Together, we will become the world's leading cancer reference laboratory.

Position Summary:

This role is responsible for supporting quality operations including reviewing documentation against standards and NeoGenomics policies/procedures. This individual will encourage teamwork and foster an environment of continuous improvement to reduce quality defects. This role is considered a hybrid role, whereby some activities may be performed remotely; however, on site presence will be required when conducting and/or supporting QA oversight of materials release, and equipment and facilities management activities.

Core Responsibilities:

• Ensures continued compliance with international, federal, local, and company regulatory standards as applicable, through continuous education of staff, review of documents against standards and NeoGenomics policies/procedures, and periodic review of changes to regulatory requirements
• Works collaboratively with cross-functional teams to ensure records follow good documentation practices and are retained as required by applicable regulatory agencies. Ensure process control measures are followed in product manufacturing and laboratory operations. This may include, but is not limited to:
  • Reviewing MQC documentation against established procedures to improve turnaround time on material release.
  • Responsible for supporting collaboration reviews of executed equipment qualifications in support of site expansion. Reviews will consist of confirmation of appropriate test case execution
  • Gather evidence and information for inclusion in validation reports
• Identifies opportunities for improvement in SOPs/WIs, forms, and processes to ensure continued compliance with regulatory and business requirements
  • Supports continual assessment of QMS data and on-going operations, by collecting quality metrics data, to ensure appropriate execution to company policies and procedures and regulatory requirements per CAP/CLIA, NY State, ISO 15189/13485, FDA 21CFR820
  • Facilitates collection of data supporting monthly Operations Quality Review Board meetings (QRB) and weekly site reviews
• Document Control and Archival:
  • Acts as an archivist for the DU Quality Assurance team and maintains physical and electronic records

Requirements:

• High School Diploma/General Equivalency Diploma required
• Bachelor’s degree in science and/or engineering, or equivalent courses preferred
• 1+ year of relevant industry Good Manufacturing (GMP) experience preferred in the IVD or Medical Device industry, or CAP/CLIA Laboratory, with 1 year of experience as an individual contributor. Knowledge of good documentation practices (GDP) preferred

PI250235098